General Description:

The Senior Manager of R&D Quality Operations & Excellence (Strategy & Structure) plays a critical role in structuring and executing quality initiatives across the R&D Quality organization. This role is focused on providing strategic oversight of portfolio and project management, supporting continuous improvement efforts, and driving process enhancements through digital innovation and change management. The Senior Manager will ensure cross-GxP strategic alignment and facilitate communication between global teams in support of the R&D Quality portfolio of work to include harmonization amongst GLP, GCP, and GVP efforts. This individual will contribute to the development and optimization of Quality Management System (QMS) processes, project management tools, and support annual goal and financial tracking, aligning R&D Quality with enterprise goals, stakeholder expectations, and regulatory requirements. Within the R&D Quality Operations & Excellence team, focus may also be allocated across key areas of quality management including but not limited to, quality insights and metrics, quality process management, process optimization, Significant Quality Event (SQE) management, Corrective and Preventive Actions (CAPAs), and Serious Breach (SB) management. These roles will also support Risk Based Quality Management (RBQM), Quality by Design (QbD), quality data analytics, and project management efforts across R&D Quality.

The position is responsible for ensuring that BeiGene’s research, development, and pharmacovigilance activities comply with all relevant regulatory requirements, internal standards, and industry’s best practices. This individual will lead a proactive and structured approach to quality assurance, quality by design, data integrity, and continuous improvement across the entire R&D Quality function by establishing an operational center of excellence within the RDQ Operations & Excellence team.

Essential Functions of the Job:

Manage and oversee R&D Quality activities which include, but are not limited to:

• Lead the portfolio management of quality projects, ensuring alignment with the organization’s strategic goals and compliance requirements.

• Oversee the planning, execution, and tracking of multiple quality improvement projects, ensuring timelines, resources, and deliverables are met.

• Implement best practices in project management, using tools and methodologies to enhance project efficiency and communication across enterprise-wide quality transformation efforts.

• Drive continuous improvement initiatives within the quality organization by identifying inefficiencies and proposing process enhancements that promote operational excellence.

• Collaborate with stakeholders to implement changes that streamline processes, reduce complexity, and improve compliance across GxP areas.

• Monitor the effectiveness of continuous improvement efforts, using data and metrics to assess impact and ensure sustainability of improvements.

• Lead efforts to improve the quality and structure of processes and procedures, ensuring they are designed and managed to prevent deviations, non-compliance, and inefficiencies.

• Partner with process owners to ensure that procedures adhere to Quality by Design (QbD) principles and support proactive risk management strategies.

• Ensure that all quality processes are documented and aligned with regulatory standards, promoting consistency across global, regional, and local operations.

• Facilitate alignment between cross-GxP functions (GCP, GMP, GVP) to ensure consistency in quality practices and processes across the organization.

• Serve as a key liaison between local, regional, and global quality teams, ensuring that organizational quality strategies are effectively implemented and adapted to local regulatory requirements.

• Lead initiatives that promote harmonization across regions, ensuring that quality processes and improvements are scalable and adaptable to different regulatory landscapes.

• Manage communication and reporting across the quality organization, ensuring that project statuses, risks, and progress are clearly communicated to senior leadership and stakeholders.

• Facilitate effective collaboration between cross-functional teams, ensuring alignment on project goals, deliverables, and timelines.

• Provide regular updates to executive teams on key projects, highlighting achievements, challenges, and upcoming milestones.

• Partner with quality partners and global stakeholders in the optimization of QMS processes, ensuring they are fit for purpose and aligned with evolving industry standards and regulatory requirements.

• Collaborate with IT and data management teams to ensure that quality tools and systems are effectively supporting quality operations and reporting needs.

• Implement process improvements that enhance transparency, reduce complexity, and promote efficiency in quality management practices.

• Drive continuous improvement initiatives and manage quality system infrastructure to support global R&D quality processes.

Additional Qualifications:

• Expert knowledge of project management preferably within biotechnology/healthcare or similar regulated environments.

• Bachelor's degree with 7+ years, Master’s degree with 5+ years, or PhD/MD/PharmD with 3+ years of project management / continuous improvement experience.

• Proven success in managing complex, cross-functional projects in a global environment.

• Experience with Clinical Trials, GxP processes (GCP, GMP, GVP) and quality management systems (QMS).

• Strong understanding of continuous improvement methodologies and their application in quality operations.

• Strong leadership skills with the ability to drive cross-functional and cross-GxP collaboration.

• Excellent communication and change management skills, with the ability to influence and inspire at all levels.

• Analytical skills with the ability to interpret data and metrics to inform decision-making and drive continuous improvement.

• Proficiency in project management tools and software, as well as MS Office (Word, Excel, PowerPoint).

Supervisory Responsibilities:

This position may include managing staff: coaching and mentoring of junior staff with training/orientation/qualification and development plan for new Quality staff when required.

Computer Skills :

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint, Project)

• History of working with Veeva QMS System is preferred

Communication & Interpersonal Skills

• Excellent verbal and written communication skills

• Ability to effectively collaborate in a dynamic environment

Significant Contacts

• Quality

• Clinical Operations

• Pharmacovigilance

• Clinical Business Operations

• Risk Based Quality Management

• Biometrics

• Medical Monitors

• Regulatory Affairs

• Global Technology Solutions

• Interacts with all levels of BeiGene

Travel:

May require up to 20% travel

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.